LIDODERM- lidocaine patch 5% patch

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)

から入手可能:

TPU Pharma, Inc.

投与経路:

TOPICAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

LIDODERM is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type, or to any other component of the product.

製品概要:

LIDODERM (lidocaine patch 5%) is available as the following: Carton of 30 patches, packaged into individual child-resistant envelopes NDC 61959-001-30 Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature]. For more information, call Endo Pharmaceuticals at 1-800-405-1388. Manufactured for: TPU Pharma, Inc. San Jose, CA 95131 Revised: December 2022

認証ステータス:

New Drug Application

製品の特徴

LIDODERM- LIDOCAINE PATCH 5% PATCH
TPU PHARMA, INC.
----------
LIDODERM®
(LIDOCAINE PATCH 5%)
R ONLY
DESCRIPTION
LIDODERM (lidocaine patch 5%) is comprised of an adhesive material
containing 5%
lidocaine, which is applied to a non-woven polyester felt backing and
covered with a
polyethylene terephthalate (PET) film release liner. The release liner
is removed prior to
application to the skin. The size of the patch is 10 cm × 14 cm.
Lidocaine is chemically designated as acetamide,
2-(diethylamino)-N-(2,6-
dimethylphenyl), has an octanol: water partition ratio of 43 at pH
7.4, and has the
following structure:
Each adhesive patch contains 700 mg of lidocaine (50 mg per gram
adhesive) in an
aqueous base. It also contains the following inactive ingredients:
dihydroxyaluminum
aminoacetate, disodium edetate, gelatin, glycerin, kaolin,
methylparaben, polyacrylic acid,
polyvinyl alcohol, propylene glycol, propylparaben, sodium
carboxymethylcellulose,
sodium polyacrylate, D-sorbitol, tartaric acid, and urea.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Lidocaine is an amide-type local anesthetic agent and is suggested to
stabilize neuronal
membranes by inhibiting the ionic fluxes required for the initiation
and conduction of
impulses.
The penetration of lidocaine into intact skin after application of
LIDODERM is sufficient to
produce an analgesic effect, but less than the amount necessary to
produce a complete
sensory block.
X
PHARMACOKINETICS
_ABSORPTION _
The amount of lidocaine systemically absorbed from LIDODERM is
directly related to
both the duration of application and the surface area over which it is
applied. In a
pharmacokinetic study, three LIDODERM patches were applied over an
area of 420 cm
of intact skin on the back of normal volunteers for 12 hours. Blood
samples were
withdrawn for determination of lidocaine concentration during the
application and for 12
hours after removal of patches. The results are summarized in Table 1.
TABLE 1
ABSORPTION OF LIDOCAINE FROM LIDODERM
NORMAL VOLUNTEERS (N = 15, 12-HOUR WEARING T